Oral hygiene gels

ABSTRACT

This invention relates to ingestible, non-foaming gels for cleaning &#34;plaque-like&#34; films from the gums of babies and endentulous persons and for conditioning these gums to disrupt the subsequent formation of the plaque-like films that tend to form on gums of babies and endentulous persons.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application a continuation-in-part of copending application Ser.Nos.: 06/927,752, filed Nov. 6, 1986 and 06/927,805, filed Nov. 6, 1986,now U.S. Pat. No. 4,950,479 the disclosures of which are herebyincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to oral hygiene gels suitable for cleaning,massaging and conditioning gums of babies and endentulous persons. Thegels of the present invention remove the "plaque-like" film that formson the gums of babies and endentulous persons. It has been observed thatthe regular use of the gels of the invention removes this film anddisrupts the subsequent formation of such plaque-like film on the gumsof babies and endentulous persons.

BACKGROUND OF THE INVENTION

Major advances have been made in the control of dental caries and gumdisease. For example, a recent National Institute of Health, (NIH)survey reported that over 50% of all U.S. school children have nocavities. The concern over caries has been replaced by the concern forgum disease. Recently, various plaque fighting and tartar control oralcare products have been successfully marketed in the U.S. The emergenceof these products and their sales success confirm the increasedawareness of plaque, gingivitis and gum disease among adults. Thisincreased awareness and concern over plaque, gum disease and oral carein general is now carrying over to the care of baby teeth and gums, bythose parents who are aware of gum disease.

Historically, the care of baby teeth was not a major concern of parents.Pediatric dental care usually started in the home about the time ayoungster could brush his or her teeth and expectorate. This usuallyoccurred about the time the full set of baby teeth were developed,usually between the ages of 2 and 3.

The NIH has sought to raise the awareness level among parents of theneed to start caring for their baby's teeth and gums prior to teethingand up through the time the child itself can effectively control theplaque formation on their teeth by regular brushing. In their pamphlet,A Healthy Mouth For You and Your Baby, the NIH states:

"Clean your baby's teeth. Baby teeth collect plaque just like adultteeth and need to be cleaned too, to prevent decay and gum disease.Usually the baby's first teeth are the two lower front ones, followed bythe two upper front ones. As soon as the first tooth appears, simplywipe it with a clean washcloth or gauze pad. As more teeth appear, brushthem with a soft brush gently and carefully every day.

By the time the baby is two and a half years old, all the baby teethwill probably be in the mouth.

About this time, children can begin using their own soft toothbrush witha very small amount of fluoride toothpaste (no more than the size of apea) but because your children cannot remove plaque, you should continueto brush your child's teeth until about the age of seven."

In his publication "Early Intervention: Prenatal and PostnatalCounseling and Infant Dental Care", Arthur Nowak suggests: "The parentshould be responsible for cleaning the infant and young child's teeth,until the time when the child can do it by himself." The authorcontinues: "In order to clean the newly erupting teeth of the very younginfant, the parent can wrap gauze around the finger, then rub the gumpads and the teeth. As more teeth erupt into the mouth, the parentshould use a small, soft bristled brush."

Most pediatricians agree: A dentifrice should not be employed until thechild and the parent have developed a cleaning routine and arecomfortable with it, particularly expectorating. It is generallyaccepted that: Early use of an adult dentifrice can cause a negativereaction in some young children because of foaming action and flavor.Note: the foaming action of the dentifrice not only causes gagging butalso decreases visibility in the child's mouth.

Most pediatricians today recommend that even before the baby teeth haveerupted, the parent should select a time during the day when theinfant's mouth can be inspected and a gauze wrapped finger inserted toclean the gums. This kind of early involvement will accustom the childto the cleaning process that is necessary for good infant oral hygiene.

Historically, teething was defined as the "eruption" or "cutting" of theteeth. Today, most researchers agree that this eruption of teeth is nota cutting process, and therefore should not be painful to the infant norshould it be responsible for the symptoms historically associated withteething i.e., increase in irritability, loss of appetite, change inbowel habits, wakefulness, some rash, fever, dribbling and drooling. Allof these symptoms, historically associated with teething, can beattributed to other factors and thus, may not be caused by teething, perse.

It has been suggested by some pediatric dentists that the discomfortassociated with teething can be minimized and in some cases prevented ifthe parent will begin cleaning baby's gums when teeth first appear underthe surface as bumps. For example, Stephen Moss DDS, MS, New YorkUniversity professor and past president of the American Academy ofPediatric Dentistry suggests: "Cleaning the gums helps, becauseplaque--an accumulation of sticky micro-organisms in the mouth--can bean irritant to baby when it builds up on gums pads. Remove the plaque,and you remove a major cause of teething pain. Begin cleaning baby'sgums once you see teeth growing under the gums, usually around six toten months."

Heretofore, the irritated gums of babies observed during teething havebeen tradionally treated with various surface analgesic products such asbenzocaine containing substances that are rubbed onto the gums for thepurpose of imparting temporary relief in the form of a "numbing" action.These products do not clean the gums, nor do they disrupt formation ofthe plaque-like coating on the soft tissue. Moreover, many young mothersexpress concern over their baby ingesting a drug such as benzocaine.Additionally, the relief obtained with these products is only temporary,less than an hour and more typically about 30 minutes, and the childappears to continue to be in pain generally exhibiting symptoms ofdiscomfort and irritability. Numerous home remedies have been reportedfor relief of teething discomfort and include rubbing "wine" and/orparagoric on the gums and around the teeth, during "fussy" periods.

There is some concern that the amount of finger pressure required toeffectively remove the plaque-like buildup from a baby's gums with agauze can often times be troublesome to the baby. Moreover, it isdifficult to thoroughly clean all the "bumps and valleys" in the infantsgums that are encountered just prior to tooth eruption with a gauzealone. Generally, this type of cleaning is perceived as an unpleasantexperience for the baby as well as by the parent doing the cleaning.

Dr. Walter Loesche, in his chapter "Decline in S. mutans AssociatedCaries Secondary to Medical Usage of Antibiotics", in MolecularMicrobiology and Immunology of S. mutans, 1986, S. Hamada et al;presented convincing evidence that reducing the microbial count duringteeth eruption is important. The author suggests, the emerging teeth andtissues are far more vulnerable to colonization by the organisms mostfrequently cited for tooth decay. General oral cleanliness includingfrequent removal of food residuals and reduction of the total bacterialcount in the mouth by frequent cleaning of the soft tissues and theemerging teeth would be an effective non-antibiotic means of controllingcolonization by these organisms.

The literature further has established that:

1. S. mutans, plaque formers, are found in all samples of microfloraobtained from babies with erupted teeth.

2. S. mutans are generally associated with primary infection.

3. Removal of the plaque-like film reduces teething pain.

4. Cleaning the gum pads help the first teeth arrive in a cleanplaque-free environment and reduces teething pain.

5. With less acid in the infants mouth (produced by S. mutans) theinfant will have an easier time teething.

The gums of endentulous persons, similar to babies, also require regularcleaning and massaging for optimum health, sense of well being andprosthesis comfort.

24% of Americans 65 and older have lost all their teeth. The number ofendentulous patients seeking initial treatment in the year 2000 isprojected at 10.4 million Americans compared to 9.0 million in 1980,thus, in spite of improved oral care, endentulism continues to increase.

There is a need for endentulous subjects to massage their gumsregularly. According to Dr. Cali in his book, The New Lower-Cost Way toEnd Gum Trouble without Surgery, 1982, i.e.. "The gums, like musoles,benefit from a massage. They need to be exercised, toughened and ensureda good blood supply". "Good circulation, the continued replacement ofexhausted blood and nutrients with fresh blood and nutrients, preventsdisease more effectively than any drug."

Dr. N. T. Nguyen in his text Your Mouth, Oral Care for All Ages, 1979,states: "Proper hygiene is absolutely essential for maintaining healthygums in denture wearers. Twice a day remove the dentures and massage thegum tissue with a soft brush or a wash cloth moistened in water. Thismassage will stimulate the circulation and maintain the health of gums."

There is therefore a definite need in the art for a product such as anoral hygiene gel suitable for cleaning, massaging and conditioning thegums of babies and endentulous persons.

In view of the foregoing it is an object of this invention to provideoral hygiene gels for the cleaning, massaging and conditioning of gums.

It is also an object of this invention to provide oral hygiene gelssuitable for cleaning, massaging and conditioning the gums of babies andendentulous persons, including those adults with some natural teethremaining.

It is a further object of the invention to provide improved methods forcleaning, massaging and conditioning gums of babies and endentulouspersons.

It is still a further object of the invention to provide methods forrelieving the discomfort normally associated with teething as well asthe discomforts of the gums experienced by endentulous persons.

It is yet another object of this invention to provide an improved methodof manufacturing the oral hygiene gels of the invention.

SUMMARY OF THE INVENTION

In accordance with the foregoing objectives, this invention providesoral hygiene gels intended for cleaning, massaging and conditioning ofgums of babies and endentulous persons to relieve the discomfortassociated with teething and the wearing of dentures. The oral hygienegels of the present invention comprise a cleaning/massaging/conditioningpreparation containing a surfactant, a coating substance and aviscosifier. The gels of the present invention are free from abrasives,analgesics and substances that alter the microflora balance of the oralcavity. These gels can be characterized as: stable, ingestible,non-foaming and substantive to the gums of babies and endentulouspersons as well as disruptive towards the "plaque-like" films that tendto form on these gums.

DETAILED DESCRIPTION OF THE INVENTION

The oral hygiene gels of this invention are ingestible non-foamingpreparations which are free from: alcohol, analgesics such asbenzocaine, and abrasives such as those generally used in dentifrices.These gels comprise a nonionic surfactant, a coating substance insolublein said surfactant, and a viscosifier. These gels are particularlysuited for cleaning plaque-like films from the gums of babies andendentulous persons and for conditioning these gums and disrupting theformation of plaque-like films on these treated gums. The gels of thepresent invention are substantive to the gums of babies and endentulouspersons.

The term gel, as used in the present invention, is defined as a"jelly-like substance formed by a suspending agent, wherein the solidand liquid phases appear continuous."

The term ingestible, as used in the present invention, is defined as"capable of being ingested with no risk of danger to the baby and/orendentulous persons ingesting the gels of the present invention."

Endentulous persons, as used in the present invention, is defined as"persons who have lost all of their natural teeth or have lost asufficient quantity of their natural teeth such that a prosthesis isrequired."

Non-foaming, for purposes of the present invention, is defined as"producing little or no foam during application of the gel to gums, suchthat the foaming, if any, will not cause discomfort or gagging to thebaby or endentulous person."

Free from alcohol, for purposes of the invention, is defined as"containing no ethanol or similar substance or containing trace amountsof same such that the characteristic burning sensation that accompaniesalcohol is not perceived by the user of the gels of the presentinvention."

Free from abrasives, for the purposes of the present invention, isdefined as "containing no abrasive, nor abrasive like substance such asthe silicas and phosphates generally used in some dentifrices, orcontaining trace amounts of these substances such that theircharacteristic abrasive action cannot be perceived by the user of thegels of the present invention."

The nonionic surfactants, suitable for use in the gel of the presentinvention include block copolymer mixtures of polyoxyalkylene compounds,i.e., poloxamers including ethylene oxide and propylene oxide poloxamermixtures; such as those described in U.S. Pat. Nos. 4,343,785;4,465,663; 4,511,563; and 4,476,107. Commercial versions of thesenonionic poloxamer surfactants are available from BASF--Wyandotte Co.,Wyandotte, Mich. and include various Pluronics such as Pluronic F108 andF127 and those Pluronics described in "Pluronic & Tetronic Surfactants",BASF Corp, 1987, at page 2. Other suitable nonionic surfactants usefulin the gels of the present invention include polyoxyethylene sorbitanmonoleate (Polysorbate 80); polyethylene glycols (Pluracols);nonylphenol ethoxylates (Surfonics); linear alcohol ethoxylates andpolyethyleneglycolparaisooctypheny/ethers (Triton's).

The nonionic surfactants in the gels of the present invention arepreferably employed at levels ranging from about 0.1% to about 10% byweight of the composition, and most preferably from about 0.5% to about4% by weight of the gels of the invention. However, in general, theamount of nonionic surfactant employed can be adjusted to provide thedesired degree of cleaning and conditioning of the gums desired.

In the present invention, a coating substance is employed in combinationwith the nonionic surfactant component of the gel. The coatingsubstances suitable for use in the gels of the present invention areinsoluble in the surfactant and can be characterized as follows, they:

1. suppress the tendency of the surfactant to foam,

2. are safely ingestible at the concentration used,

3. have an affinity for gum surfaces,

4. are neutral, inert and do not support microbiological activity,

5. modify the surface energy properties of gums such that it is moredifficult for food particles, cellular debris and various plaqueprecursors and formers to attach to these surfaces,

6. form a thin, transparent coating that does not buildup on the gumsand is removed by the normal clearing and flushing action of the mouth,

7. impart a pleasant "smooth" feeling to the gums, and

8. retain various flavors and substances on surfaces of gums, impartingan unexpected prolonged flavor effect.

Suitable coating substances for the gels of the present inventioninclude various silicones insoluble in the nonionic surfactants used inthe present invention including polyalkysiloxanes such aspolydimethysiloxanes, such as Dow Corning 360 Medical Fluid (viscositiesof 20 to 12,500 centistokes); Dow Corning Q7-2587 Simethicone Emulsion;Dow Corning 200 Fluids, (60,000 to 100,000 centistokes) with thechemical composition CH₃ SiO[SiO(CH₃)₂ ]_(n) Si(CH₃)₃ ; all availablefrom Dow Corning, Midland, Mich.

The coating substances of the gels of the present invention arepreferably employed at levels ranging from about 0.01 to about 0.5% byweight of the composition; and most preferably from between about 0.05and about 0.25% by weight of the gel. In general, the amount of coatingsubstances employed is adjusted to provide the desired degree ofconditioning and substantivity desired.

The weight ratio of nonionic surfactant to coating substance in the gelsof the present invention range from between about 20:1 to about 2:1 andpreferably from between about 17:1 to about 3:1.

The viscosifiers suitable for the gels of the present invention includethose viscosifiers suitable for gelling the surfactant/coating substancemixtures of the present invention. These include various cellulose gumssuch as carboxymethy/cellulose (CMC). These anionic, water solublepolymers derived from cellulose are available commercially from AqualonCompany and described as sodium carboxymethy/cellulose. They aredescribed in detail in "Aqualon Cellulose Gum", Aqualon Company, 1988.Also various hydroxypropy/cellulose, nonionic water-soluble polymersavailable commercially as Klucel from the Aqualon Company. These aredescribed in detail in "Klucel Hydroxypropy/cellulsoe" Oct., 1987.Further viscosifiers suitable for the gels of the present inventioninclude; cellulose ethers available commercially as Methocel from theDow Chemical Company and described in detail in "Methocel CelluloseEthers", Technical Handbook #192-1062-88-JB, Dow Chemical Company.

The viscosifiers suitable for the gels of the present invention arepreferably employed at levels ranging from about 0.5 to about 10% byweight of the composition, and most preferably from between about 1.5 toabout 6.0% by weight of the gel. In general, the amount of viscosifieremployed is adjusted to provide the desired gel properties sought forthe purposes of the present invention.

The combination of certain nonionic surfactants with certain coatingsubstances in a gel, wherein the latter is insoluble in the former andthe gel cleans, massages and conditions gums of babies and endentulouspersons to remove plaque-like films that tend to form on these gums andto disrupt the subsequent formation of such plaque-like films on saidgum surfaces is novel. The relief from teething discomfort and denturediscomfort experienced when these gels are regularly applied to the gumsof babies and endentulous persons is unexpected.

Furthermore, the gels of the present invention do not foam, are freefrom abrasives and analgesics. They can be used without discomfort,gagging, etc, and they can be swallowed and do not need to be rinsedfrom the surfaces of the gums. The gels of the invention are substantiveto the gums of children and endentulous persons and when not rinsed awaythey tend to remain and disrupt the subsequent formation of plaque-likefilms onto the surfaces of gums.

The "plaque-like" film that tends to form on the gums of babies, priorto and during teething, and on the gums of endentulous persons whogenerally wear prosthesis is believed to include bacteria in apolysaccharide matrix. In some denture wearers this film is considered acontributing factor to Candida yeast infections. In childrenexperiencing teething, this plaque-like film is identified as a hostsubstrate for S. mutans and has been suggested as a major contributor toteething discomfort. This discomfort is described as a "gingivitis-like"condition that occurs on the bumps of the baby's gums prior to andduring teething.

Most commercial products available today for control of plaque andgingivitis rely on antimicrobial, and antibacterial and/or astringentproperties to control these bacterial colonies. Such products can not beused with babies who can not expectorate. Moreover, these commercialproducts have non-specific, broad-spectrum bactericidal properties andtend to disrupt the critically balanced flora in a baby's mouth. Suchdisruption of the flora on a regular basis could prove more harmful thanthe gingivitis condition being treated and is generally not recommendedby pediatricians.

The regular cleaning, massaging and conditioning of gums of babies aswell as endentulous persons, with the gels of the present inventionusing a finger, a gauze wrapped finger or a soft bristled brusheffectively removes the plaque-like film from the tender gums, massagesthe gums and leaves a coating on the gums that conditions the gums anddisrupts the formation of such plaque-like films later on.

The reduction in teething discomfort achieved with regular use of thegels of the present invention and the method of treating the gums of thepresent invention should also be accompanied by a reduction in dentalcaries that is generally associated with plaque buildup on babies gums,as well as reduce other oral disorders generally associated with plaquebuildup.

The reduction in plaque-like buildup on the gums of denture wearersachieved with the gels and methods of treating the gums of the presentinvention should reduce some of the discomfort normally associated withdenture wearing as well as improve the health and muscle tone of thegums of denture wearers. Regular massaging of the gums of endentulouspersons with the gels of the present invention would reduce thefrequency of denture adjustment and generally improve the fit andcomfort of dentures and the cleanliness of the gums. Additionally, theremoval of "plaque-like" films from the surfaces of the gums willdramatically reduce "denture breath" a condition that generallyaccompanies the wearing of dentures.

The cleaning of plaque-like film from the gums of babies and endentulouspersons with the gels of the present invention is achieved with aminimum of mechanical action and without foaming. After the cleaningstep with babies there is no need to expectorate nor to rinse the mouth.The coating that remains on the baby's gums leaves the gums feelingsmooth and clean. This coating contains an appropriate flavorant, suchthat the cleaning/massaging/conditioning exercise is a pleasantexperience which encourages compliance, i.e., regular cleaning.

The film remaining on the gums of babies and endentulous persons is notmetabolizable by resident oral cavity microorganisms and is substantiveto the surface of the gums. This is to be contrasted with natural filmformers such as lecithin which are also substantive to the gums butwhich are metabolizable and support biological activity. See forexample, Menaker, The Biologic Basis of Dental Caries, Chapter 16,Gibbon and Hoote, Ann Rev. of MICROBOLOGY, 29, pp. 19-44; and Hayes, J.Dent. Res 632. pp. 2-5.

The coating that remains on the gums after applying the gels of thepresent invention is inert and is substantive to the gums. As long asthis film remains on the gums it:

1. disrupts the subsequent formation of "plaque-like" films on the gums,

2. imparts a smooth feeling, and

3. prolongs the pleasant perception of the flavorant used in the gel.This prolonged flavor perception is particularly novel and unexpectedand is a critical contributing factor in the high compliance profile ofthe gels of the present invention with babies as well as endentulouspersons.

Cleaning of an infants gums should start once teeth growing under thegums appear as bumps, usually around age six to ten months. Preferablythe gel of the invention is applied to a two-inch square gauze pad thatis wrapped around the finger. Slight pressure is applied to the gums asthe gel is rubbed over the surfaces of the gums. Such cleaning isrecommended twice daily, morning and night. When the first molars appeara small soft-bristled brush usually replaces the gauze pad and teeth arebrushed at least once a day but preferably twice, morning and night.

According to the American Dental Association, "Regular cleaning andmassaging of yours gums with a soft bristled brush is as important ascleaning your dentures." Preferably a pea size quantity of the gel ofthe present invention is placed onto a brush or an index finger and thenthe gum on the lower left side of the mouth is thoroughly cleaned,massaged and conditioned. This step is repeated with a second pea sizeapplication of the gel to the gum on the lower right side of the mouth.These steps are repeated with the left and right sides of the upper gum.The user can expectorate if necessary, but it is not necessary to rinse.This process is to be repeated prior to and after wearing dentures. Forbest results this cleaning, massaging and conditioning is carried outfor 30 seconds to 1 minute at least twice a day.

High compliance potential is a critical element of the gels of thepresent invention. That is, the pleasant mouth feel and low foamingproperties of these gels and the prolonged pleasant taste and mouth feelthat remains after using the gels of the present invention encouragesregular use of the gels of the invention. There is a "it's working"perception of the gels of the invention without negative medicinalconnotations which tend to reduce usage and lower compliance potential.

Additional adjuvants can be included in the gels of the presentinvention including:

a. natural sweeteners such as sorbitol-70. Lycasan (hydrogenated glucosesyrup) and xylitol powder in concentrations ranging from between about10 and about 40 percent by weight.

b. artificial sweeteners such as sodium saccharin and Nutrasweet® inconcentrations from between about 0.05 and about 0.2 percent by weight.

c. humectants such as glycerine, propylene glycol and mixtures thereofat concentrations from between about 5 and about 20 percent by weight.

d. preservatives such as methylparabenz, propyl parabenz, potassiumsorbate, sodium benzoate, and mixtures thereof in concentrations frombetween about 0.05 and about 0.25 percent by weight.

A buffering ingredient may also be added to the gels of the invention inorder to prevent natural degradation of the flavoring components.Generally, the pH of these gel compositions is adjusted to between about3.0 and about 8.5, preferably from about 4.5 to about 6.5. The bufferingingredients such as a weak organic acid such as a weak organic acid suchas citric acid or an alkali metal salt of a weak organic acid, forinstance, sodium benzoate, sodium citrate, sodium phosphate, orpotassium tartrate is generally added in an amount of about 0.1 to about1.0 percent by weight.

The present invention will be further illustrated with reference to thefollowing examples which aid in the understanding of the presentinvention, but which are not to be construed as limitations thereof. Allpercentages reported herein, unless otherwise specified, are percent byweight. All temperatures are expressed in degrees Celsius.

EXAMPLES

The following examples provide a synopsis of oral hygiene gelpreparations of the invention and illustrate the unexpected resultsobtained by the use of the gels disclosed herein.

EXAMPLE 1

Several gel formulations of the present invention suitable for thecleaning and massaging of babies gums were prepared. These gels had thefollowing general formulation where percentages are by weight:

    ______________________________________                                        Component      Percent                                                        ______________________________________                                        Pluronic F-127 2.00                                                           Silicone 1500  0.12                                                           Sorbital 70    34.00                                                          Glycerine      5.00                                                           Propylene glycol                                                                             10.00                                                          Flavor         0.75                                                           Methyl Parabenz                                                                              0.15                                                           Propyl Parabenz                                                                              0.05                                                           Potassium Sorbate                                                                            0.15                                                           Sodium saccharin                                                                              0.075                                                         Citric acid    0.17                                                           Viscosifier    (Type and                                                                     concentration                                                                 varies as discussed                                                           below).                                                        Deionized water                                                                              Balance                                                        ______________________________________                                    

A mixing vessel was charged with water, sorbital 70, potassium sorbate,methyl parabenz, propyl parabenz, sodium saccharin and citric acid whilestirring with an overhead mizer. The vessel was heated to 60° C. and thecontents transferred to a Waring Blender.

In a separate vessel, Pluronic F-127 and Silicone 1500 were heated andstirred to effect a hot-melt emulsion. Flavor was added to the hot-meltemulsion and the flavored, hot-melt emulsion was then added to themixture in the Waring Blender.

A mixture of propylene glycol/glycerin was stirred while the specificsolid viscosifying agent of choice was added to form a suspension.(These are described in detail below). This suspension was added slowlyto the Waring Blender with vigorous agitation (390 watts). After 15minutes the Waring Blender was stopped and the resultant gel was pouredinto tubes or jars for storage use.

Using the procedure and general formula described above, variousviscosifiers were used at one or more concentrations to prepare a seriesof gels suitable for cleaning and massaging baby gums. Specifically:Klucel GF was used at 5% by weight; Methocel K4M at concentrationsranging from 0.5% to 3.3% by weight; CMC 7LF at concentrations from 5 to10% by weight; CMC9M31F at concentrations from 1 to 3% by weight andCMC7MF at concentrations ranging from 2 to 4% by weight.

All of these formulations of the present invention were useful as babygum and teeth cleaners.

Further Examples illustrative of various gels of the present inventionsuitable for cleaning and massaging baby teeth and gums are set forth inTable I.

                  TABLE I                                                         ______________________________________                                        EXAMPLE                      COATING                                          #        SURFACTANT   (%)    COMPOSITION                                                                              (%)                                   ______________________________________                                         2       Pluronic      .5    Medical    0.10                                           F-127 (solid)       Emulsion AF                                       3       Pluronic     1.0    Dow 1500   0.05                                           F-127 (solid)                                                         4       Pluronic     2.0    Dow 1500   0.10                                           F-127 (solid)                                                         5       Pluronic     3.5    Dow 1500   0.20                                           F-127 (solid)                                                         6       Pluronic     2.0    Dow 1500   0.02                                           F-127 (solid)                                                         7       Pluronic     2.0    Dow 1500   0.05                                           F-127 (solid)                                                         8       Pluronic     2.0    Dow 1500   0.20                                           F-127 (solid)                                                         9       Pluronic     2.0    Dow 1500   0.50                                           F-127 (solid)                                                        10       Pluronic     2.0    Dow 200 cs 100                                                                           0.10                                           F-127 (solid)                                                        11       Pluronic     2.0    Dow 200 cs 350                                                                           0.10                                           F-127 (solid)                                                        12       Pluronic     2.0    Dow 200 cs 1000                                                                          0.10                                           F-127 (solid)                                                        13       Pluronic     2.0    Dow 360 Med. cs                                                                          0.10                                           F-127 (solid)       12,500                                           14       Pluronic P85 2.0    Dow 1500   0.10                                           (paste)                                                              15       Pluronic P85 1.0    Dow 360 Med cs                                                                           0.10                                           (paste)             12,500                                           16       Pluronic L64 2.0    Dow 1500   0.10                                           (liquid)                                                             17       Pluronic L64 1.0    Dow 200 cs 100                                                                           0.05                                           (liquid)                                                             ______________________________________                                         *pH adjusted with citric acid or baking soda as required. Lycasan brand,      hydrogenated glucose syrup (Rochette). ?                                 

    EXAMPLE  NATURAL              ARTIFICIAL                                      #        SWEETENER    (%)     SWEETENER (%)                                   ______________________________________                                         2       Sorbitol 70  35      Sodium    .08                                                                 saccharin                                        3       Sorbital     25      Sodium    .10                                            powder               saccharin                                        4       Sorbitol 70  40      Sodium    .05                                                                 saccharin                                        5       Sorbitol 70/ 25/5    Sodium    .10                                            Lycasan              saccharin                                        6       Lycasan      35      Nutrasweet                                                                              .10                                    7       Sorbitol 70  30       "        .10                                    8       Xylitol powder                                                                             25       "        .10                                    9       Sorbitol 70  30       "        .10                                   10       Sorbitol 70  40      Sodium    .05                                                                 saccharin                                       11       Sorbitol 70  30      Sodium    .10                                                                 saccharin                                       12       Xylitol powder                                                                             20      Sodium    .20                                                                 saccharin                                       13       Sorbitol     20      Sodium    .08                                            powder               saccharin                                       14       Sorbitol 70  40      Sodium    .05                                                                 Saccharin                                       15       Sorbitol 70  30      Sodium    .10                                                                 Saccharin                                       16       Sorbitol 70  35      Sodium    .07                                                                 saccharin                                       17       Sorbitol 70 &                                                                              25/10   Sodium    .07                                            Lycasan              saccharin                                       ______________________________________                                        EX-                                                                           AMPLE # HUMECTANT      (%)    VISCOSIFIER                                                                             (%)                                   ______________________________________                                         2      Glycerine/propylene                                                                          5/10   CMC 7 MF  3.5                                           glycol                                                                 3      Glycerine/propylene                                                                          5/10   CMC 7 LF  8.0                                           glycol                                                                 4      Glycerine/propylene                                                                          5/10   Methocel K4M                                                                            2.0                                           glycol                                                                 5      Glycerine/propylene                                                                          5/10   Carragenan                                                                              1.0                                           glycol                                                                 6      Propylene glycol                                                                             20     CMC 9M31F 2.5                                    7      Glycerin       10     Gum Arabic                                                                              5.0                                    8      Glycerin propylene                                                                           7/13   Klucel GF 5.0                                           glycol                                                                 9      Glycerin propylene                                                                           7/13   CMC 7 LF  6.0                                           glycol                                                                10      Glycerin       10     CMC 9M31F 2.0                                   11       "             10     CMC 9M31F 3.0                                   12       "             10     CMC 7 MF  3.0                                   13       "             10     CMC 7 MF  4.0                                   14      Glycerin       15     CMC 7 MF  5.0                                   15      Glycerin propylene                                                                           10/5   CMC 9M31F 2.0                                           glycol                                                                16      Propylene glycol                                                                             20     Klucel GF 4.0                                   17      Glycerin       10     Methocel K4M                                                                            3.0                                   ______________________________________                                        EXAMPLE                                                                       #        PRESERVATIVE         (%)                                             ______________________________________                                         2       Methyl parabenz, propyl parabenz,                                                                  .15/.05/.15                                              potassium sorbate                                                     3       Methyl parabenz, propyl parabenz,                                                                  "                                                        potassium sorbate                                                     4       Methyl parabenz, propyl parabenz,                                                                  "                                                        potassium sorbate                                                     5       Methyl parabenz, propyl parabenz,                                                                  "                                                        potassium sorbate                                                     6       Sodium Benzoate      .25                                              7       Methyl parabenz, propyl parabenz                                                                   .15/.05                                          8       Potassium sorbate    .25                                              9       Potassium sorbate    .10                                             10       Methyl parabenz, propyl parabenz,                                                                  .15/.05/.15                                              potassium sorbate                                                    11       Methyl parabenz, propyl parabenz,                                                                  "                                                        potassium sorbate                                                    12       Methyl parabenz, propyl parabenz,                                                                  "                                                        potassium sorbate                                                    13       Methyl parabenz, propyl parabenz,                                                                  "                                                        potassium sorbate                                                    14       Sodium benzoate      .25                                             15       Potassium sorbate    .15                                             16        "                   "                                               17        "                   "                                               ______________________________________                                                                             DE-                                      EXAMPLE                              IONIZED                                  #        FLAVOR       (%)       pH*  WATER                                    ______________________________________                                         2       IFF: 252, 453, 244                                                                         .45/.15/.15                                                                             4.5  44.72                                     3       "            "         5.5  49.25                                     4       "            "         5.0  39.75                                     5       "            "         5.0  49.10                                     6       "            .10       4.0  57.85                                     7       "            "         6.0  52.65                                     8       "            "         5.0  65.40                                     9       "            "         4.5  41.30                                    10       IFF 252      .5        5.0  45.00                                    11       "            .5        4.5  53.95                                    12       "            .5        4.0  63.85                                    13       "            .5        5.5  62.97                                    14       IFF 261      .1        3.5  37.50                                    15       "            .2        4.0  51.45                                    16       None         --        5.0  38.68                                    17       None         --        5.0  50.73                                    ______________________________________                                    

EXAMPLE 18

Several gel formulations of the present invention suitable for thecleaning and massaging of gums of endentulous persons were prepared.

These gels had the following formulation, where percentages are byweight:

    ______________________________________                                        Compound         Percent                                                      ______________________________________                                        Pluronic F-127   2.00                                                         Silicone AF30    0.4                                                          Glycerin         5.00                                                         Sorbitol-70      34.00                                                        Flavor           0.5                                                          Propylene glycol 10.00                                                        Potassium sorbate                                                                              0.15                                                         Methyl parabenz  0.15                                                         Propyl parabenz  0.05                                                         Sodium saccharin 0.075                                                        Aqueous saturated citric                                                                       (adjusted to pH of 5)                                        acid solution                                                                 Viscosifier      (type and concen-                                                             tration varies as                                                             described below)                                             Deionized water  Balance                                                      ______________________________________                                    

A mixing vessel was charged with water, potassium sorbate, methylparabenz, propyl parabenz, sodium saccharin and Sorbitol-70, whilestirring, and then, the mixture was added to a Waring Blender. The pHwas adjusted to 5.0 with an aqueous saturated citric acid solution.

The Pluronic F-127 and Silicone AF30 were heated and stirred to effect ahot-melt emulsion. Flavor was added to the hot-melt emulsion. Theflavor, hot-melt emulsion was slowly added with vigorous agitation to aWaring Blender. (390 watts)

A vessel was charged with propylene glycol and glycerin with stirringwhile the solid viscosifier was added. The resulting suspension wasadded slowly to the rapidly stirred Waring Blender, stirring wascontinued for 15 minutes and then the resultant gel was transferred totubes and/or jars for testing and use.

Using the procedure and general formula described above, variousviscosifiers were used at one or more concentrations to prepare a seriesof gels suitable for cleaning and massaging the gums of endentulouspersons. Specifically, CMC7MF at 3%, CMC7HF at 1.5% and CMC9M31F at 2.5%by weight and were added to a sample of the formula described above toprepare a series of gels suitable for cleaning, massaging andconditioning the gums of endentulous persons. All of the resultant gelformulations of the present invention were useful as gum cleaning,massaging and conditioning gels for endentulous persons.

Examples illustrative of various gels of the present invention suitablefor cleaning and massaging gums of endentulous persons can be obtainedfrom the gels set forth in Table I, by adjusting the artificialsweetener: natural sweetener ratio to accommodate adult taste preferenceand by substituting mouth-freshening flavors in the range of 0.05 to2.0% by weight such as oil of spearment, oil of peppermint, oil ofclove, and complex flavors such as:

IFF vanillamint 101

IFF Spearmint 744,

IFF Natural ming 619

IFF Spearmint 082 and the like.

The present invention has been described in detail, including thepreferred embodiments thereof. However, it will be appreciated thatthose skilled in the art, upon consideration of the present disclosure,may make modifications and/or improvements on this invention and stillbe within the scope and spirit of this invention as set forth in thefollowing claims.

What is claimed is:
 1. An oral hygiene method for cleaning, massagingand conditioning gums of edentulous persons and babies and infants priorto teething, and up through the time the child itself can effectivelycontrol plaque formation, by regular brushing, comprising the steps ofremoving and disrupting plaque-like films on said gums with a gelsuitable for cleaning, massaging and conditioning gums of babies andendentulous persons, wherein:A. said gel is free from:1. abrasive, 2.analgesic, and
 3. substances that alter the microflora balance of theoral cavity; B. said gel comprises;1. a nonionic surfactant,
 2. acoating substance insoluble in said surfactant, wherein the weight ratioof said nonionic surfactant to said coating substance is from betweenabout 50:1 and about 1:1 and;
 3. a viscosifier; and C. said gel ischaracterized as being:1. stable,
 2. ingestible,
 3. non-foaming, 4.substantive to the gums of babies and endentulous persons,
 5. disruptivetowards the formation of plaque-like films on the gums of babies andendentulous persons, and having a
 6. pH of from between about 3.0 andabout 8.5.
 2. An oral hygiene method according to claim 1 wherein thenonionic surfactant is selected from, mixtures of polyoxyakylenepoloxamers.
 3. An oral hygiene method according to claim 2 wherein saidpoloxamer are mixtures of polyoxypropylene and polyoxethylene compounds.4. An oral hygiene method according to claim 1 wherein the coatingsubstance is selected from the group consisting of silicones,polyalkylsiloxanes and mixtures thereof.
 5. An oral hygiene methodaccording to claim 4 wherein the polyalkylsiloanes arepolydimethylsiloxanes.
 6. An oral hygiene method according to claim 1wherein the viscosifier is selected from the group consisting of sodiumcarboxymethyl-cellulose, hydroxypropylcellulose, cellulose ethers andmixtures thereof.
 7. An oral hygiene method according to claim 2 whereinthe pH is from between about 3.0 and about 8.5, and the weight ratio ofnonionic surfactant to coating composition is from between about 20:1and about 2:7.
 8. An oral hygiene preparation according to claim 2wherein the concentration of nonionic surfactant is from between about0.1% and about 10% by weight.
 9. An oral hygiene method reparationaccording to claim 4 wherein the concentration of coating substance isfrom between about 0.01 and about 0.5% by weight.
 10. An oral hygienemethod according to claim 6 wherein the concentration of viscosifier isfrom between about 0.5% and about 10% by weight.
 11. An oral hygienemethod according to claim 2 wherein the surfactant is a poloyamer ofethyleneoxide and propyleneoxide at about 2% by weight, the coatingsubstance is a polydimethy/siloxane at about 0.12% by weight; and theviscosifier is carboxymethy/cellulose at 2.%% by weight.